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510(k) K251395

The Rialto™ SI Fusion System by Medtronic Sofamor Danek USA, Inc. — Product Code OUR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2025
Date Received
May 5, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sacroiliac Joint Fixation
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

sacroiliac joint fusion

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